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Two medicines, side by side

Olmesartan vs amlodipine

Olmesartan and amlodipine are both labeled for high blood pressure. Drugs@FDA records approvals of olmesartan since 2002 and of amlodipine since 1992. Pharmacies paid $0.0805 per olmesartan medoxomil 20 mg tablet and $0.0102 per amlodipine besylate 5 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. In FDA's classes, olmesartan is an angiotensin 2 receptor blocker and amlodipine a calcium channel blocker.

Check it at the source: the olmesartan FDA label on DailyMed (effective September 23, 2025); the amlodipine FDA label on DailyMed (effective February 15, 2023).

Highlights of the olmesartan record

Olmesartan (Benicar) · label of September 23, 2025

Boxed warning

FETAL TOXICITY When pregnancy is detected, discontinue Benicar as soon as possible ( 5.1 , 8.1 ). Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus ( 5.1 , 8.1 ). WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue Benicar as soon as possible ( 5.1 , 8.1 ).

Used for

From the label: indications

Benicar is indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. […]

On the market

Earliest approval on file
April 25, 2002
Generic labelers
30 labelers
Pharmacy cost
$0.0805 per tablet

Supply and safety

Shortage
No current entry
Recalls
2

Highlights of the amlodipine record

Amlodipine (Norvasc) · label of February 15, 2023

Used for

From the label: indications

NORVASC is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: • Hypertension ( 1.1 ) o NORVASC is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. […]

On the market

Earliest approval on file
July 31, 1992
Generic labelers
42 labelers
Pharmacy cost
$0.0102 per tablet

Supply and safety

Shortage
No current entry
Recalls
30

Source: FDA drug labels via openFDA (Olmesartan label of September 23, 2025, Amlodipine label of February 15, 2023); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)

How do olmesartan and amlodipine differ on the record?

In FDA's classes, olmesartan is an angiotensin 2 receptor blocker and amlodipine a calcium channel blocker.

How each works, in its label's words: Olmesartan, “Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin converting enzyme (ACE, kininase II).”; Amlodipine, “Amlodipine is a dihydropyridine calcium antagonist (calcium ion antagonist or slow‑channel blocker) that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac …”

Only the olmesartan label carries a boxed warning.

Generics: olmesartan since 2016; amlodipine since 2005 (Drugs@FDA).

OlmesartanAmlodipine
Labeled forHigh blood pressureHigh blood pressure, Angina, Heart attack and coronary artery disease
Pharmacologic classAngiotensin 2 Receptor BlockerCalcium Channel Blocker, Dihydropyridine Calcium Channel Blocker
How it works (label)Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin converting enzyme (ACE, kininase II).Amlodipine is a dihydropyridine calcium antagonist (calcium ion antagonist or slow‑channel blocker) that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle.
Half-life (label)Olmesartan appears to be eliminated in a biphasic manner with a terminal elimination half-life of approximately 13 hours.n/a
Earliest approval on file (Drugs@FDA)April 25, 2002July 31, 1992
First generic approvedOctober 26, 2016October 3, 2005
Generic labelers (NDC)30 labelers42 labelers
Pharmacy cost (NADAC, each one's most listed form; strengths differ)$0.0805 per tablet (Olmesartan medoxomil 20 mg tablet)$0.0102 per tablet (Amlodipine besylate 5 mg tablet)
12-month price change+1%-10%
Boxed warningYesNo
Shortage nowNo current entryNo current entry
Recalls recorded230
FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used)35,743409,186
DEA schedulenonenone

Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)

What next?

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